CACIPLIQ20 is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Glycosaminoglycans are implied 1) in the stabilization of the micro-environment of cells, known as extracellular matrix, by binding to structural proteins, and 2) in the cell communication by protecting growth factors. At the site of a lesion, glycosaminoglycans are degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By replacing damaged glycosaminoglycans, CACIPLIQ20 provides a protective function and restores the matrix architecture and the cell communication, a process known as Matrix Therapy.

As for now, three non-controlled pilot studies have been carried out on small populations. They have shown a substantial enhancement of chronic wounds state after treatment with CACIPLIQ20. Therefore, the purpose of this new controlled study is to determine whether CACIPLIQ20 can shorten diabetic neuropathic plantar ulcers healing when the off-loading is mandatory.

The study's main hypothesis is that CACIPLIQ20 application on a non-healing diabetic plantar ulcer in an off-loading mandatory context would reinitiate the natural process of tissue regeneration and lead to total wound closure faster than following standard wound care.

Healing rate, defined as the difference between two lesion rates at different times

Number of declared full wound healings [ Time Frame: 8, 15, 30, 45 and 60 days ] [ Designated as safety issue: No ]

Number of declared full wound healings during time, defined as non-oozing wound closure without any reopening after no less than 15 days, ascertained by the principal investigator and another member of his team

Number of wounds leading to amputation [ Time Frame: 8, 15, 30, 45 and 60 days ] [ Designated as safety issue: No ]

Number of wounds causing new amputations during time, as recorded after surgical measures sustained by patients

Pain experienced during time [ Time Frame: Recruitment, 8, 15, 30, 45 and 60 days ] [ Designated as safety issue: No ]

Pain experienced by patients, assessed with Numerical Rating Pain Scale (0 to 10) and amount of painkillers used

Diabetic patients have a 25% risk to develop foot ulcers during their life, and one diabetes-induced amputation is performed every 30 seconds in the world. Textbook-case of perforating foot ulcer (Malum Perforans Pedis) is caused by a mechanical impairment : only a thoroughly observed discharge may lead to good wound care and, ultimately, healing. Thus, this study proposes the utilization of an nonremovable windowed Fiberglass Cast Boot, a technique which has led to healing in 6 to 8 weeks for 95% of neuropathic foot ulcers treated that way.

As 80% of amputations are caused by non-healing ulcers, it appears obvious that enhancing foot wounds healing could reduce amputation rate and in that way fairly improve diabetic patients' quality of life.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Perforating non-ischemic plantar ulcer with neuropathy in a diabetic patient

Wound not healing for no less than 6 weeks, based on recruitment examination

Wound surface spanning from 1 cm² to 10 cm²

Foot off-loaded by a non-removable windowed, fiberglass cast boot

Age of inclusion ≥ 18 years

A contraceptive method must be used for women of childbearing age

Realization of a preliminary physical examination

Exclusion Criteria:

Wound not located on the foot, or ischemic, with edema, erythema, maceration or eczema

Infection clinically approved (Fever, pus...)

Osteitis

Known hypersensitivity to heparin

Treatment with Negative Pressure Wound Therapy within 30 days prior to enrollment

Treatment ongoing or within 30 days prior to enrollment with growth factors or other biotechnology products

Treatment ongoing or within 12 months prior to enrollment with hyperbaric oxygen therapy

Patient with liver or kidney failure

Patient with a known heavy condition that could require corticosteroid, anti-inflammatory or immunosuppressant treatments

Patient already enrolled in a therapeutic clinical study focusing on an experimental molecule

Pregnant or breastfeeding woman, or likely to be

Non-affiliation to the French social security system

Patient unable to attend to scheduled medical monitoring due to geographical, social or mental reasons

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474473